Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS3556080 A
Publication typeGrant
Publication dateJan 19, 1971
Filing dateApr 8, 1968
Priority dateApr 8, 1968
Also published asDE2100542A1, DE2100542B2
Publication numberUS 3556080 A, US 3556080A, US-A-3556080, US3556080 A, US3556080A
InventorsHein Gary L
Original AssigneeLincoln Lab Inc
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Skin allergy testing device
US 3556080 A
Abstract  available in
Images(1)
Previous page
Next page
Claims  available in
Description  (OCR text may contain errors)

United States Patent lnventor Gary L. Hein Decatur, Ill.

Appl. No. 719,318

Filed Apr. 8, 1968 Patented Jan. 19, I971 Assignee Lincoln Laboratories, Inc.

Decatur, III. a corporation of Indiana SKIN ALLERGY TESTING DEVICE 7 Claims, 6 Drawing Figs.

U.S. Cl 128/2, 128/329 Int. Cl A6lb 5/00, A6 1 b 17/20 Field of Search 128/329,

[56] References Cited UNITED STATES PATENTS 2,522,309 9/1950 Simon 128/2 3,034,507 5/1962 McConnell et a1. 128/253 3,289,670 12/1966 Krug et a1. 128/2 Primary Examiner-William E. Kamm Assistant Examiner-G. F. Dunne Attorney-Norman Lettrin ABSTRACT: A device for effecting multiple skin tests simultaneously on spaced portions of the skin of a nonplanar pan of the human body is provided by a plurality of multiple-point pressure puncture heads each connected by an individual, relatively flexible, arm to a relatively rigid handle. In one form of device the points on the heads may be dipped into antigenic material, In a second form, each head has antigenic material preassembled on the multiple-point heads.

SKIN ALLERGY TESTING DEVICE BACKGROUND OF THE INVENTION This invention relats'to a skin-testing device for effecting multiple skin tests simultaneously. 1

Skin testing of persons to determine what materials they may be allergic to has become an essential medical diagnostic tool. It is well known to attempt to apply biologic materials to spaced portions of the skin simultaneously in effecting skin testing of a' number of materials. See Laub', U.S. Pat. Nos. 2,235,436 and 2,841,138 and Simon, U.S. Pat. No. 2,522,309. It has also been known to load a liquid biologic on multiplepoint scariflers and to retain the load on the points by surface tension of the liquid cooperating with the capillarity developed by closely adjacent points of the scarifier. See Kravitz, U.S. Pat. No. 3,136,314 and Burelle et al., U.S. Pat. No.3,29l,l29. j

The instant invention seeks to embody a plurality of multipie-point scarifiers in an improved device for effecting multiple spaced skin tests simultaneously.

When multiple spaced skin tests are applied simultaneously, a relatively large area of the body may be involved. It is difficult to find a large planar body portion or a body portion which readily admits of equal reaction to a testing apparatus which has multiple scarifiers. In Laub, U.S. Pat. No. 2,235,436, the tests are arranged on a flexible strip adapted for adherence to the skin. In Simon, US. Pat. No. 2,522,309, scratch type scarifiers are used wherein the interiorly located scarifiers are obscured from view by thehorizontally extended handle from which they depend, so that one cannot be sure that all scarifiers will effect scratching simultaneously.

' The object of this invention is to provide an improved device for effecting multiple skin tests simultaneously by pressure pu'nctures, and wherein the physician has full view of each scarifier being used and is able to effect substantially identical pressure punctures with each test head of the instrument, even on a nonplanar body portion, thereby insuring uniformity of testing.

A further objectof this invention is to provide an improved testing instrument that is characterized by its simplicity and ef- BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates my new skin-testing instrument and illustrates its use on the forearm of a patient being tested;

FIG. 2 is a bottom plan view of the instrument of FIG. 1;

FIG. 3 is a side elevational view of the instrument of FIG. 1;

FIG. 4 is an end elevational view of the instrument of FIG. I; a

FIG. 5 illustrates one method of loading liquid antigenic material onto the points of scarifier heads of the instrument; and

FIG. 6 is a fragmentary enlarged cross-sectional view illustrating a modified form of the instrument, particularly in the means for preassembling the biological or antigenic material on the points of the scarifier heads of the instrument.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, one form of the instrument of this invention is illustrated at 10 and its use is shown on the forearm F of a patient, the hand of the physician or nurse applying the test being designated P.

As can best be seen in FIGS. I-4, the instrument might be termed centipede shaped and includes an elongated barlike spine or handle 12 having a plurality of elongated connector means 14 extending, in outrigger fashion, laterally from both sides of the spine 12 in directions transversely to the longitudinal axis of handle or spine 12. At thedistal end of each armlike connector means l4 is a multiple-point type pressure puncture head 16.

The multiple-point head 16 is ofthe type generally disclosed in Kravitz. U.S. Pat. No. 3.136.314 and includes a round base 18, a rectangular or round raised platform 20 centrally ofbase l8, and nine pressure-type points 22 clustered centrally onto platform 20 so as to create a capilllarityv effect between the points for holding liquid material in the interstices or spaces between the points 22.

In order that the spine or handle 12 berigid and easily grasped, it is formed with substantial height, about nine-sixteenth inch relative to thickness, about one-eighth inch. The length of bar 12 is about 4 inches. This shape for handle 12 permits easy grasping by the fingers, as seen in FIG. 1; and avoids blocking of view of the'various heads 16. At the same time, the handle 12 provides substantial strength in its plane, which is used to effect transfer of vertically applied forces from handle 12 through arms 14 to all the multiple-pointed heads 16 so as to effect a plurality of multiple-point pressure puncture tests simultaneously on spaced portions of the skin of a nonplanar body part, as shown in FIG. I. The armlike connector means 14 each joins the lower handle 12 at equally spaced points, about thirteen-sixteenth inch on centers, adjacent the lower edge 12a. The arms 14 are rod-like with a transverse dimension of about one-sixteenth inchthree thirty-seconds inch. Each arm has a horizontal portion 140. an

' elbow 14b intermediate the ends of arm 14, and a downturned and slightly outwardly inclined upright section 14g.

While the base 18 of pressure puncture head 16 is round, the distal end of arm 14 connects to :head 16 adjacentan edge of head 16 closest to spine 12. A triangular brace web 14d, lying in the plane of arm 14, is provided diametrically of the back side of base 18 and between base 18 and arm portion 140, so as to rigidify the attachment of the multiple-pointed head 16 to the distal end of arm 14 without substantially increasing the amount of material used or obstructing the view of each head 16 and its points 22.

Each elongated arm 14 is so small in cross section as to provide relative flexibility both at the juncture of arm portion 14a with relatively rigid spine 12, and also at theelbow 14b. Thus,

there may be some bending of arm 14 at its connection with handle 12 in a plurality of directions, such as both in the plane of arm 14 and transversely to said plane.

I The entire instrument is integrally molded from a' plastic material making the same inexpensive but effective for its intended purpose. After a single use, the instrument may be discarded, thus avoiding any infection, such as transmission of infection hepatitis to a later user.

In the loading of antigens, allergens, or other biologic substances onto the points 22 prior to application as in FIG. 1, two systems are suggested. The first system shown in FIG. 5 utilizes a rectangular biologic-carrying base 30 constructed to have 12 wells 32 defined therein for cooperation with the 12 multi-pointed heads 16 of the centipedelike instrument of FIGS. 1-4. The diameter of each well .32 is of a size to admit the circular base 18 of head 16. Each well carries liquid, or semiliquid or semidried material therein positioned to have the points 22 of the head 16 immersed therein. If desired, each head 16 may be provided with an annular flange 16a, of greater diameter than base 18 and located at the upper end of base 18, for engagement with portions of base 30 to limit entry of heads 16 into wells 32.

Each well 32 may be filled to a desired depth with a different biological material, such as an allergen, with different specific materials being assigned to different wells in a predetermined pattern or arrangement known to the person applying the material and later reading the results of the test.

The second system of loading the biologic substances on the points 22 of a head 16 is illustrated in FIG. 6 and utilizes the principles disclosed in Burelle et al., U.S. Pat. No. 3,291,129.

I 20 and entering groove 40. The arrangement holds the liquid material 44 in position against platform 20 with points 22 immersed therein. and without leakage. so that when a tube 42 is pulled off, the points 22 are exposed carrying biologic 44 thereon in the interstices or spaces between points 22.

The entire arrangement of FIG. 5. including base 30 and instrument assembled. or the separated portions thereof, may

be provided packaged in sterile condition in a box or other suitable container (not shown). After removing the instrument from its package and uncovering the wells 32, the wells may be filled to desired levels and the heads 16 are to be dipped as shown in FIG. 5, after which the multiple tests are applied as in FIG. 1. Alternatively, in the system of FIG. 6. the instrument 10 is supplied with each head 16 carrying preassembled thereon the biologic material 44 in tube 42. The tube 42 for each head 16 may then be removed, and the points 22 remain loaded with biologic 44, after which the instrument is used as in FIG. 1.

It will be understood that in applying the instrument as in FIG. 1, the physician or nurse is able to easily see which heads 16 have had their points 22 forced into the skin in a manner so as to properly elicit a test reaction. Where the body portion is not planar. only a slight rocking motion of the handle 12 is necessary to bring each head 16 into proper operative skinpuncturing association with the selected skin area. During such rocking motion. the multiple contacts of a plurality of other heads 16 with the body prevents any slippage of the instrument and thus avoids undesired scratching with points 22.

While there has been shown and described a particular embodiment of this invention, it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the invention and, therefore, it is intended in the appended claims to cover all such changes and modifications as fall within the true spirit and scope of the invention.

lclaim:

1. A device for effecting multiple skin tests simultaneously on spaced portions of a nonplanar body part comprising, in combination: a relatively rigid, elongated handle; a plurality of multiple-point, skin-puncturing heads located laterally outwardly of both longitudinal sides of the handle. so that the handle does not obstruct view of the puncturing heads when being used to effect skin tests; and a plurality of elongated connector means for connecting the skin-puncturing heads to the handle; each connector means being of small size dimension relative to its length and being spaced from adjacent connector means so as not to obstruct view of the puncturing heads. each connector means extendinglongitudinally transversely to the longitudinal axis of the a handle and interconnecting at its distal end to one of the multiple-point heads so that the heads may all be pressured from the single handle to effect a plurality of multiple-point pressure puncture tests simultaneously on spaced portions of the skin of a nonplanar body part. the connector means extending outwardly and angling downwardly of the handle means so as to locate the mul-v tiple-point heads in a plane spaced substantially below the handle means.

2. A device as in claim 1 wherein each elongated connector means provides a mounting for the multiple-point skin-puncturing head that permits flexing of each connector means in a plurality of directions at the point of connection of the connector means to the handle. I

3. A device as in claim 2 wherein each elongated connector means includes an elbow section intermediate the ends of the connector means to permit additional flexibility.

4. A device as in claim 1 wherein the handle. multiple-point heads and connector means are integrally molded.

S. A device as in claim 1 wherein each elongated connector head so as to rigidify the connection of the head to the con- IICCIOI' means.

6. A device as in claim 1 wherein the handle is an elongated barlike body having a greater height than width so as to have strength for transmitting vertically applied forces from the handle to all the multiple-point heads, while affording maximum visibility of the multiple-point heads during a test-applying operation and affording easy gripping of the handle by the fingers.

7. A device as in claim 6 wherein the connector means connect to the handle adjacent the lower edge thereof, and the multiple-point heads are located in a plane spaced below said lower edge of the handle.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2522309 *Dec 1, 1948Sep 12, 1950Simon Frank AAllergy testing instrument
US3034507 *May 10, 1960May 15, 1962American Cyanamid CoIntracutaneous injection device
US3289670 *Mar 9, 1964Dec 6, 1966Milo Bundy CorpDevice for abrading and applying biologicals to the skin of a patient
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3688764 *Aug 20, 1970Sep 5, 1972Bard Hamilton Co IncIntracutaneous injection system
US3906933 *Apr 5, 1974Sep 23, 1975Lovida AgMethod and apparatus for determination of skin type
US4205689 *Sep 5, 1978Jun 3, 1980Aller-Screen, Inc.Allergy testing system
US4222392 *May 23, 1979Sep 16, 1980Alier-Screen, Inc.Allergy testing device with vented base
US4270548 *Dec 11, 1979Jun 2, 1981Aller-Screen, Inc.Allergy testing method
US4292979 *Apr 9, 1979Oct 6, 1981Inglefield Jr Joseph TAllergy testing apparatus
US4304241 *Feb 12, 1980Dec 8, 1981Aller-Screen, Inc.Skin testing device
US4453926 *Jun 2, 1983Jun 12, 1984Institut Merieux, Societe AnonymeScarifier
US4459360 *Oct 5, 1981Jul 10, 1984Mast Medical Industries, Ltd.Diagnosis, filaments, coatings, allergies, kits, antibodies, uncubation, joining
US4483348 *Mar 25, 1982Nov 20, 1984Nathan SherSkin testing device
US4802493 *Feb 17, 1987Feb 7, 1989Maganias Nicholas HDevice and method for allergy testing
US5097810 *Apr 6, 1990Mar 24, 1992Henry FishmanAllergy testing apparatus and method
US5139029 *Dec 3, 1991Aug 18, 1992Henry FishmanAllergy testing apparatus and method
US5551441 *Dec 9, 1994Sep 3, 1996Pitesky; IsadoreAllergen applicator apparatus
US5588441 *Jun 7, 1995Dec 31, 1996Fishman; HenryAllergy testing apparatus with variably spaced test using sites
US5605160 *Jun 5, 1995Feb 25, 1997Fishman; HenryAllergy testing apparatus with variably spaced test testing sites
US5647371 *Apr 12, 1995Jul 15, 1997Greer Laboratories, Inc.Skin testing device loading method
US5671753 *Jun 27, 1995Sep 30, 1997Pitesky; IsadoreDisposable multiple allergen testing apparatus
US5673705 *Aug 30, 1996Oct 7, 1997Pitesky; IsadoreAllergen applicator apparatus
US5692518 *Jul 8, 1994Dec 2, 1997Rachman Scientific, Inc.Skin test applicator
US5735288 *Sep 30, 1996Apr 7, 1998Fishman; HenryAllergy testing apparatus with variably spaced test testing sites
US5738108 *Mar 14, 1997Apr 14, 1998Lincoln Diagnostics, Inc.System for multi-site skin testing and components thereof
US5749836 *Mar 26, 1996May 12, 1998Hsiao; Ray-LingQuantitative skin allergic test device
US5792071 *Jan 11, 1996Aug 11, 1998Lincoln DiagnosticsSystem for multi-site skin testing and components thereof
US5944671 *Oct 14, 1998Aug 31, 1999Greer Laboratories, Inc.Skin test applicator
US6095988 *Sep 4, 1998Aug 1, 2000Greer Laboratories, Inc.Autoloader and skin testing system
US6206838Aug 1, 2000Mar 27, 2001Greer Laboratories, Inc.Autoloader and skin testing system
US6334856May 21, 1999Jan 1, 2002Georgia Tech Research CorporationMicroneedle devices and methods of manufacture and use thereof
US6503231Jun 10, 1998Jan 7, 2003Georgia Tech Research CorporationMicroneedle device for transport of molecules across tissue
US6554777 *Aug 31, 2001Apr 29, 2003Gary L. Hein, Jr.Multi-site skin-test system and method
US6595947 *May 22, 2000Jul 22, 2003Becton, Dickinson And CompanyTopical delivery of vaccines
US6611707Dec 2, 1999Aug 26, 2003Georgia Tech Research CorporationMicroneedle drug delivery device
US6743211Nov 23, 1999Jun 1, 2004Georgia Tech Research CorporationDevices and methods for enhanced microneedle penetration of biological barriers
US7027478Dec 20, 2001Apr 11, 2006Biovalve Technologies, Inc.Microneedle array systems
US7226439Jun 4, 2003Jun 5, 2007Georgia Tech Research CorporationMicroneedle drug delivery device
US7344499Dec 2, 1999Mar 18, 2008Georgia Tech Research CorporationMicroneedle device for extraction and sensing of bodily fluids
US7731968Sep 7, 2007Jun 8, 2010Becton, Dickinson And CompanyTopical delivery of vaccines
US7963935 *Apr 20, 2002Jun 21, 2011Alza CorporationMicroprojection array having a beneficial agent containing coating
US8257324May 21, 2007Sep 4, 2012Georgia Tech Research CorporationMicroneedle drug delivery device
US8361037Sep 19, 2002Jan 29, 2013Valeritas, Inc.Microneedles, microneedle arrays, and systems and methods relating to same
US8469900Nov 30, 2011Jun 25, 2013Lincoln Diagnostics, Inc.Allergy testing device and method of testing for allergies
US8597199Oct 11, 2010Dec 3, 2013Ziv HarishReduced-pain allergy skin test device
US8708966Aug 9, 2010Apr 29, 2014Georgia Tech Research CorporationMicroneedle devices and methods of manufacture and use thereof
US8920375Sep 23, 2002Dec 30, 2014Valeritas, Inc.Gas pressure actuated microneedle arrays, and systems and methods relating to same
US20130231583 *Feb 28, 2013Sep 5, 2013Donna RekkerthMethods and Compositions for Injection Delivery
DE3102857A1 *Jan 29, 1981Dec 3, 1981Merieux Inst"vorrichtung zur skarifikation"
DE29811266U1 *Jun 24, 1998Nov 4, 1999Kerner KayVorrichtung zum Lagern und Auftragen von mindestens zwei Testsubstanzen
EP1006867A1 *Feb 18, 1998Jun 14, 2000Lincoln Diagnostics, Inc.System for multi-site skin testing and components thereof
WO1980000531A1 *Jul 30, 1979Apr 3, 1980Brennan LAllergy testing system
WO1983001308A1 *Jul 1, 1982Apr 14, 1983Mast Medical Ind LtdAllergy screening system and method of making and using same
WO1997024977A1 *Jan 8, 1997Jul 17, 1997Lincoln Diagnostics IncSystem for multi-site skin testing and components thereof
WO1998041139A1Feb 18, 1998Sep 24, 1998Lincoln Diagnostics IncSystem for multi-site skin testing and components thereof
Classifications
U.S. Classification600/556, 606/183
International ClassificationA61B17/20
Cooperative ClassificationA61B17/205
European ClassificationA61B17/20B
Legal Events
DateCodeEventDescription
Sep 13, 1982AS01Change of name
Owner name: LINCOLN LABORATORIES, INC.
Owner name: MERIEUX LABORATORIES INC
Effective date: 19820830
Sep 13, 1982ASAssignment
Owner name: LINCOLN LABORATORIES, INC.
Free format text: CHANGE OF NAME;ASSIGNOR:MERIEUX LABORATORIES INC;REEL/FRAME:004036/0918
Effective date: 19820830